Lakatos 1986.
| Methods | A single‐centre, randomised, prospective controlled trial | |
| Participants | 204 outborn infants Inclusion criteria: premature infants, 751 to 2000 g BW, born between 1 January 1983 and 6 March 1984 Exclusion criteria: congenital abnormalities, death before 6 h of life |
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| Interventions | Intervention group (n = 100) BW < 1500 g: D‐penicillamine intravenously started within 12 h after birth, 300 mg/kg/day (divided in 3 doses) x 3 days, then 50 mg/kg/day (in a single dose) until 2 weeks of age BW 1500‐2000 g: D‐penicillamine intravenously started within 12 h after birth, 300 mg/kg/day (divided in 3 doses) x 3 days; additional 50 mg/kg/day doses if they required oxygen beyond 3 days Control group (n = 104). No placebo was used in controls Once ROP developed after 6 weeks of age, D‐penicillamine 50 mg/kg/day was given to infants in the control group for 3 weeks |
|
| Outcomes | Death before discharge Any ROP in survivors | |
| Notes | Follow‐up at 1 year of age for anthropometry and neurodevelopment presented in separate study (Vekerdy‐Lakatos 1987) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Authors do not provide the exact method of random sequence generation |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| Blinding (performance bias and detection bias) All outcomes | High risk | No blinding |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Group assignment not concealed from paediatricians, but ophthalmologists doing ROP examinations were masked to study group |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes of ROP reported on the majority of enrolled infants |
| Selective reporting (reporting bias) | Unclear risk | The study protocol was unavailable |